REMS Targeting Off-Label Use Helps Aegerion’s Lomitapide Clear FDA Panel
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee votes 13-2 that Aegerion’s lomitapide should be approved for homozygous familial hypercholesterolemia despite serious hepatic and other risks as long as every effort is made to prevent off-label use.